Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
OXYTETRACYCLINE HYDROCHLORIDE
INTERVET ( ISRAEL) LTD
CUTANEOUS SPRAY
OXYTETRACYCLINE HYDROCHLORIDE 25 MG/ML
CUTANEOUS
Required
INTERVET PRODUCTIOND SRL, ITALY
For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs:*Treatment of foot infections caused in particular by: Dichelobacter nodosus, Fusobacterium necrophorum and other Fusobacterium spp., and Bacteroides spp. *Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions.
2021-09-30
The format of this leaflet was determined by the Ministry of Health and its content checked and approved in October 2016. CONSUMER PACKAGE INSERT FOR A VETERINARY MEDICINAL PRODUCT The medicine is dispensed with a veterinarian’s prescription only For veterinary use only 1. NAME OF THE MEDICINE: ENGEMYCIN SPRAY VETERINARY CUTANEOUS SPRAY 2. COMPOSITION: Active ingredients Oxytetracycline hydrochloride 25.00 mg/ml (equivalent to oxytetracycline 23.15 mg/ml) Inactive ingredients Patent blue V (E131) 1.25 mg/ml A list of inactive ingredients is detailed in the section “Further Information”. 3. WHAT IS THE MEDICINE INTENDED FOR: For the treatment of the following infections caused by or associated with organisms sensitive to oxytetracycline in cattle, sheep and pigs. Foot infections caused in particular by: _Dichelobacter nodosus_, _Fusobacterium _ _necrophorum_, and other _Fusobacterium_ ssp., and _Bacteroides_ spp. Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions. Pharmacotherapeutic group: antibiotics for topical use, tetracyclines. 4. CONTRAINIDICATIONS: Do not spray on the udder of the treated animal in order to prevent traces of the active ingredient in the milk. Do not use in the case of hypersensitivity to oxytetracycline or to any of the inactive ingredients. 5. SIDE EFFECTS None. Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects of Drug Treatment” found on the Ministry of Health homepage (www.health.gov.il) that directs you to the online form for reporting side effects, or by entering the link: https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe ctMedic@moh.gov.il 6. TARGET ANIMALS: Cattle, sheep and pigs. 7. METHOD OF ADMINISTRATION AND DOSAGE: A suspension in the form of a cutaneous spray. FOR TOPICAL USE ONLY. 8. ADMINISTRATION OF MEDICINAL PRODUCT: Shake well before use. The spray container is designed for use in either the Baca dokumen lengkapnya
_The format of this leaflet was determined by the Ministry of Health and its content was checked and _ _approved in _ October 2016 _ _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Engemycin Spray Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains Active substance: Oxytetracycline hydrochloride 25.00 mg (equivalent to oxytetracycline 23.15 mg Excipients: Patent blue V (E131) 1.25 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, suspension Green to green-blue suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs: Treatment of foot infections caused in particular by: _Dichelobacter nodosus_, _Fusobacterium _ _necrophorum_ and other _Fusobacterium_ spp., and _Bacteroides_ spp. Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions. 4.3 CONTRAINDICATIONS Do not use for treatment of teats in order to prevent the product from getting into milk. Do not use in animals in cases of hypersensitivity to oxytetracycline or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS The animals should be treated in a well ventilated area. Do not spray in or near the eyes. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Because of the risk of sensitisation and contact dermatitis, the user should avoid skin contact. Wear appropriate impermeable gloves whil Baca dokumen lengkapnya